En fase III-undersøgelse af BNT324 versus docetaxel ved metastatisk kastrationsresistent prostatakræft
En fase III, randomiseret, åben-label undersøgelse af BNT324 versus docetaxel med prednison/prednisolon ved metastatisk kastrationsresistent prostatakræft
This study will test whether BNT324 is safe and works better against metastatic castration-resistant prostate cancer (mCRPC) than the current standard of care (SoC) chemotherapy, which is docetaxel (given together with the steroid medicines prednisone or prednisolone). The study will include participants with mCRPC that have been previously treated with androgen receptor pathway inhibitor, but with no previous taxane-based systematic chemotherapy for mCRPC.
The main goals of this study are:
- To find out if BNT324 helps participants live longer without their cancer getting worse (radiographic progression-free survival [rPFS]).
- To find out if BNT324 helps participants live longer overall (overall survival [OS]).
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
The study consists of a screening period (up to 28 days), a treatment period with 21-day cycles, and an after-treatment period that includes a 30-day safety follow-up period and a long-term survival follow-up period.
Treatment continues until the cancer clearly gets worse (in scans, based on blinded independent central review [BICR] assessment or investigator's decision), side effects become unacceptable, the participant chooses to stop, or the study ends.
Participants are put into one of two groups in a 1:1 ratio, which means they will have an equal chance to be in either treatment group, i.e., BNT324 group, or docetaxel plus prednisone/prednisolone group (current SoC). An independent committee will help ensure participant safety, by regularly reviewing safety and early results.
For each participant, the treatment and follow-up periods are projected to be up to ~58 months.
Undersøgelsestype
Tilmelding (Anslået)
Fase
- Fase 3
Kontakter og lokationer
Studiekontakt
- Navn: BioNTech clinical trials patient information
- Telefonnummer: +49 6131 9084
- E-mail: patients@biontech.de
Studiesteder
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Southport, Australien, 4215
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- Tasman Onco Research Pty Ltd
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Brussels, Belgien, 1200
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- Cliniques Universitaires Saint-Luc
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Cambridge, Det Forenede Kongerige, CB2 0QQ
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- Addenbrooke's Hospital
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Cardiff, Det Forenede Kongerige, CF14 2TL
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- Velindre Cancer Centre
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Leeds, Det Forenede Kongerige, LS9 7TF
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- St James's University Hospital
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London, Det Forenede Kongerige, SW3 6JJ
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- Royal Marsden Hospital
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Newcastle upon Tyne, Det Forenede Kongerige, NE7 7DN
- Rekruttering
- Freeman Hospital
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Southampton, Det Forenede Kongerige, SO16 6YD
- Rekruttering
- Southampton General Hospital
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Sutton, Det Forenede Kongerige, SM2 5PT
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- Royal Marsden Hospital
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California
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Santa Barbara, California, Forenede Stater, 93105
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- Sansum Clinic
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Colorado
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Aurora, Colorado, Forenede Stater, 80012
- Rekruttering
- Rocky Mountain Cancer Centers
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Florida
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Fort Myers, Florida, Forenede Stater, 33901
- Rekruttering
- Florida Cancer Specialists- Fort Myers
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St. Petersburg, Florida, Forenede Stater, 33701
- Rekruttering
- Florida Cancer Specialists- St. Petersburg
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West Palm Beach, Florida, Forenede Stater, 33401
- Rekruttering
- Florida Cancer Specialists- West Palm Beach
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Georgia
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Atlanta, Georgia, Forenede Stater, 30318
- Rekruttering
- Piedmont Cancer Institute
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Illinois
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Niles, Illinois, Forenede Stater, 60714
- Rekruttering
- Illinois Cancer Specialists
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Peoria, Illinois, Forenede Stater, 61615
- Rekruttering
- Illinois CancerCare PC
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Maryland
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Rockville, Maryland, Forenede Stater, 20850
- Rekruttering
- Maryland Oncology Hematology
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New York
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Albany, New York, Forenede Stater, 12206
- Rekruttering
- NYOH Albany Cancer Center
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White Plains, New York, Forenede Stater, 10601
- Rekruttering
- White Plains Hospital
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Ohio
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Cincinnati, Ohio, Forenede Stater, 45242
- Rekruttering
- Oncology/Hematology Care, Inc.
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South Carolina
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Myrtle Beach, South Carolina, Forenede Stater, 29572
- Rekruttering
- START Carolinas
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Tennessee
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Nashville, Tennessee, Forenede Stater, 37203
- Rekruttering
- Tennessee Oncology
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Nashville, Tennessee, Forenede Stater, 37203
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- SCRI Oncology Partners
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Texas
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Austin, Texas, Forenede Stater, 78731
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- Texas Oncology South Austin
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Houston, Texas, Forenede Stater, 77024
- Rekruttering
- Texas Oncology Gulf Coast
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Tyler, Texas, Forenede Stater, 75702
- Rekruttering
- Texas Oncology, P.A. - Tyler
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Wichita Falls, Texas, Forenede Stater, 76310
- Rekruttering
- Texas Oncology - West Texas
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Virginia
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Fairfax, Virginia, Forenede Stater, 22031
- Rekruttering
- Virginia Cancer Specialists PC
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Norfolk, Virginia, Forenede Stater, 23502
- Rekruttering
- Virginia Oncology Associates
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Beijing, Kina, 100142
- Rekruttering
- Beijing Cancer Hospital
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Beijing, Kina, 100034
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- Peking University First Hospital
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Changsha, Kina, 410005
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- The First Affiliated Hospital of Hunan Normal University
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Chengdu, Kina, 610041
- Rekruttering
- West China Hospital, Sichuan University
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Chongqing, Kina, 400072
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- The Second Affiliated Hospital of Chongqing Medical University
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Fuzhou, Kina, 350001
- Rekruttering
- Fujian Medical University Union Hospital
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Hangzhou, Kina, 310022
- Rekruttering
- Zhejiang Cancer Hospital
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Hangzhou, Kina, 310016
- Rekruttering
- Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University
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Hefei, Kina, 230601
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- Second Hospital of Anhui Medical University
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Nanchang, Kina, 330006
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- The First Affiliated Hospital of Nanchang University
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Nanjing, Kina, 210008
- Rekruttering
- Nanjing Drum Tower Hospital
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Shanghai, Kina, 200032
- Rekruttering
- Shanghai Cancer Center
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Shanghai, Kina, 200072
- Rekruttering
- No. 10 People's Hospital of Shanghai
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Wenzhou, Kina, 325000
- Rekruttering
- The First Affiliated Hospital of Wenzhou Medical University
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Wuhan, Kina, 430079
- Rekruttering
- Hubei Cancer Hospital
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Wuhan, Kina, 420104
- Rekruttering
- Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
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Wuhu, Kina, 241001
- Rekruttering
- Yijishan Hospital of Wannan Medical College
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Yantai, Kina, 264000
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- Yantai Yuhuangding Hospital
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Krakow, Polen, 30-727
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- Pratia MCM Krakow
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Warsaw, Polen, 02-781
- Rekruttering
- National Research Institute of Oncology - National Research Institute (NIO-PIB)
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Dresden, Tyskland, 1307
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- Universitätsklinikum Carl Gustav Carus
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Hamburg, Tyskland, 22763
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- Asklepios Klinik Altona
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Key Inclusion Criteria:
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Are male adults (defined as ≥18 years of age or of an acceptable age according to local regulations at the time of giving informed consent).
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Must have documented progressive prostate cancer based on at least one of the following criteria:
- Serum/plasma PSA progression, by local laboratory, defined as two consecutive increases in PSA over a previous reference value, each measured sequentially at least 1 week apart. The PSA value at screening is required to be ≥1.0 ng/mL.
- Radiographic soft tissue progression as per PCWG3-modified RECIST v1.1.
- Radiographic progression of bone disease: evaluable disease or new bone lesion(s) by bone scan per PCWG3 criteria.
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Had previously received one or two prior androgen receptor pathway inhibitor treatments and experienced disease progression during or after a minimum of 8 weeks of therapy.
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Must not have received systemic cytotoxic chemotherapy, including taxane-based chemotherapy, for mCRPC.
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Must have had prior orchiectomy and/or have ongoing androgen-deprivation therapy and a castrate-level of serum/plasma testosterone (<50 ng/dL or <1.7 nmol/L). Participant being treated with luteinizing hormone-releasing hormone agonists or antagonists must continue such treatment throughout the study.
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Must have an Eastern Cooperative Oncology Group performance score of 0 or 1.
Key Exclusion Criteria:
- Have received prior treatment with B7-H3 targeted therapy, including B7-H3 ADCs.
- Have uncontrolled or significant cardiovascular disease, as defined in the protocol.
- Have a history of (non-infectious) interstitial lung disease (ILD)/pneumonitis that required steroids or have current ILD/pneumonitis.
NOTE: Other protocol defined Inclusion/Exclusion criteria apply.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
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Eksperimentel: BNT324
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Intravenous infusion
Andre navne:
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Aktiv komparator: Docetaxel plus prednison/prednisolon
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Intravenous infusion Oral |
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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rPFS assessed by BICR
Tidsramme: From randomization to end of study, i.e., up to 58 months
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By arm. rPFS is defined as time from randomization to radiographic disease progression per Prostate Cancer Working Group 3 (PCWG3)-modified Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) criteria, or death from any cause, whichever occurs first. |
From randomization to end of study, i.e., up to 58 months
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OS
Tidsramme: From randomization to end of study, i.e., up to 58 months
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By arm. OS is defined as time from randomization to death from any cause. |
From randomization to end of study, i.e., up to 58 months
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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Time to first subsequent therapy (TFTS)
Tidsramme: From randomization to end of study, i.e., up to 58 months
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By arm. TFST is defined as time from randomization to initiation of the first subsequent systemic anticancer therapy or death, whichever occurs first. |
From randomization to end of study, i.e., up to 58 months
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Objective response rate (ORR)
Tidsramme: From randomization to end of study, i.e., up to 58 months
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By arm. ORR is defined as the proportion of participants in whom a confirmed complete response (CR) or partial response (PR) (per PCWG3-modifed RECIST v1.1 as assessed by BICR) is observed as best overall response. |
From randomization to end of study, i.e., up to 58 months
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Duration of response (DOR)
Tidsramme: From randomization to end of study, i.e., up to 58 months
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By arm. DOR is defined as time from first objective response (confirmed CR or PR per PCWG3-modified RECIST v1.1 criteria as assessed by BICR) to first occurrence of objective tumor progression (progressive disease per PCWG3-modified RECIST v1.1 criteria as assessed by BICR) or death from any cause, whichever occurs first. |
From randomization to end of study, i.e., up to 58 months
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Time to pain progression (TTPP)
Tidsramme: From randomization to safety follow-up visit (30 days after the last dose), i.e., up to 58 months
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By arm. TTPP is defined as time from randomization to pain progression as determined by Brief Pain Inventory-Short Form Item 3 "worst pain in 24 hours" and opiate analgesic use (Analgesic Quantification Algorithm score). |
From randomization to safety follow-up visit (30 days after the last dose), i.e., up to 58 months
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rPFS as assessed by investigator
Tidsramme: From randomization to end of study, i.e., up to 58 months
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By arm. rPFS is defined as time from randomization to radiographic disease progression per PCWG3-modified RECIST v1.1 criteria, or death from any cause, whichever occurs first. |
From randomization to end of study, i.e., up to 58 months
|
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Time to first symptomatic skeletal-related event (SSRE)
Tidsramme: From randomization to end of study, i.e., up to 58 months
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By arm. Time to first SSRE is defined as time from randomization to first occurrence of any of the following SSREs:
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From randomization to end of study, i.e., up to 58 months
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Time to prostate-specific antigen (PSA) progression (by central lab testing results)
Tidsramme: From baseline to end of treatment visit, i.e., up to 58 months
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By arm. Time to PSA progression is defined as time from randomization to PSA progression per PCWG3 criteria. |
From baseline to end of treatment visit, i.e., up to 58 months
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PSA response (by central lab testing results)
Tidsramme: From baseline to end of treatment visit, i.e., up to 58 months
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By arm. PSA response is defined as having a post-baseline PSA reduction ≥50% from baseline with a consecutive confirmation assessment at least 3 weeks later per PCWG3 criteria. |
From baseline to end of treatment visit, i.e., up to 58 months
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Number and percentage of participants with treatment-emergent adverse events (TEAEs) including Grade ≥3, serious, and fatal TEAEs
Tidsramme: From the start of study treatment until 30 days after the last dose of study treatment or until start of new systemic anticancer therapy, whichever occurs first, i.e., up to 58 months
|
TEAEs by relationship and by arm. |
From the start of study treatment until 30 days after the last dose of study treatment or until start of new systemic anticancer therapy, whichever occurs first, i.e., up to 58 months
|
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Number and percentage of participants with dose interruptions, reductions or discontinuations of study treatment due to TEAEs
Tidsramme: From the start of study treatment until 30 days after the last dose of study treatment or until start of new systemic anticancer therapy, whichever occurs first, i.e., up to 58 months
|
By arm. |
From the start of study treatment until 30 days after the last dose of study treatment or until start of new systemic anticancer therapy, whichever occurs first, i.e., up to 58 months
|
Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Studieleder: BioNTech Responsible Person, BioNTech SE
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- BNT324-03
- 2025-524445-27-00 (Ctis)
- 2025 (U.S. NIH-bevilling/kontrakt)
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
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Studerer et amerikansk FDA-reguleret enhedsprodukt
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